Mitral Valve Flange Fixation for Rapid Annulus Attachment
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Solution Overview
Problem
Current heart valve repair and replacement techniques are time-consuming and inefficient, particularly in attaching annuloplasty devices to the valve annulus, which can lead to prolonged surgery times and potential complications such as paravalvular leakage.
Innovation Solution
A medical device comprising a first loop-shaped support and a flange unit connected to the support, which is configured to abut the heart valve and be arranged against the annulus for easy and durable fixation, thereby facilitating quick attachment and reducing surgery time.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional suture techniques are used to attach annuloplasty devices to the valve annulus, then secure fixation is achieved, but surgery time is significantly prolonged
Solution Approach 1:
The fixation system is divided into separate components: the annuloplasty device with integrated fixation elements and the valve annulus. The fixation elements (barbs, hooks, or clamps) are pre-integrated into the annuloplasty device structure, allowing for rapid deployment without time-consuming suturing operations.
Solution Approach 2:
The traditional mechanical suture-based fixation system is replaced with an integrated mechanical fixation system using barbs, hooks, or clamps that are pre-attached to the annuloplasty device. This substitution eliminates the need for separate suture threading and tying operations, dramatically reducing surgery time while maintaining secure fixation.
2Manufacturing precision
If annuloplasty ring is severely malpositioned, then restitching is required to reposition, but this extends surgery time and increases complexity
Solution Approach 1:
The fixation elements (barbs, hooks, or clamps) are pre-integrated into the annuloplasty device during manufacturing, ensuring proper positioning is maintained from the moment of deployment. This preliminary integration prevents malpositioning issues that would require time-consuming restitching operations.
Solution Approach 2:
The fixation elements are strategically positioned at specific locations on the annuloplasty device to ensure accurate positioning relative to the valve annulus. This localized quality control at critical fixation points ensures proper alignment and eliminates the need for corrective restitching operations.
3Ease of operation
If flange unit is added to the loop-shaped support, then fixation ease and speed are improved, but device complexity increases
Solution Approach 1:
The flange unit is merged with the loop-shaped support to form an integrated structure. This combination allows the flange to provide fixation functionality while the loop-shaped support maintains its structural role, achieving ease of fixation without requiring entirely separate components.
Solution Approach 2:
The flange unit serves multiple functions: it provides a broad surface area for attachment to the valve annulus, facilitates secure fixation through integrated fixation elements, and maintains the structural integrity of the device. This multi-functionality reduces the need for additional separate components, balancing ease of operation with device complexity.
Data Source
AI summary
A kit for replacement of a native mitral valve includes a loop-shaped element with a curved body and having at least two full turns between first and second ends and a longitudinal center axis. A first end portion is sized for positioning on an atrial side of the native mitral valve and the second end portion is sized for positioning on a ventricular side of the native mitral valve. At least a part of the second end portion has a larger radius of curvature than at least a part of the first end portion. A prosthetic mitral valve is arranged to be supported within the native mitral valve by at least the second end portion of the loop-shaped element.


